Durbin, Duckworth, Schneider Applaud New EPA Rule Restricting Dangerous Ethylene Oxide Emissions

03.14.24

Durbin, Duckworth, Schneider Applaud New EPA Rule Restricting Dangerous Ethylene Oxide Emissions

WASHINGTON - U.S. Senate Majority Whip Dick Durbin (D-IL), a member of the Senate Environmental Justice Caucus, U.S. Senator Tammy Duckworth (D-IL), co-founder and co-chair of the Senate Environmental Justice Caucus, and U.S. Representative Brad Schneider (D-IL-10), Co-Chair of the bipartisan Congressional Ethylene Oxide Task Force, today applauded the U.S. Environmental Protection Agency (EPA) for finalizing its new rule, Final Amendments to Strengthen Air Toxics Standards for Ethylene Oxide Commercial Sterilizers, that tightens emissions limits, monitoring, and controls for commercial sterilization facilities that use ethylene oxide (EtO), a carcinogen. The rule, which covers plants like Medline in Waukegan, Illinois, will result in a 90 percent reduction in emissions from commercial sterilizers due to the installation of effective and achievable air pollution controls and prevent toxic emissions from reaching the communities in which these facilities operate.

"EPA is tasked with protecting the public from environmental harms, including toxic ethylene oxide that has proven to be carcinogenic. I am relieved that EPA is taking a monumental step forward in cementing a historic rule that will hold commercial stabilizers accountable for the emissions put off by their operations," said Durbin. "With this new rule, I hope that we can prevent more communities like Willowbrook from being exposed to harmful air that shackles Illinoisans with serious diagnoses, including cancer. Our communities deserve better, and with this new rule, Illinoisans can breathe cleaner, safer air."

"For too long, EtO emissions from commercial sterilization facilities have damaged public health in surrounding communities and significantly increased the risk of nearby residents developing cancer in their lifetimes," said Duckworth. "As co-chair and co-founder of the Senate's first-ever Environmental Justice Caucus, I've long pushed the EPA to take stronger actions on EtO and I'm proud this new rule will help us reduce these toxic emissions, advance environmental justice and change the fate of health outcomes in disadvantaged communities in Illinois and across the country, bringing us closer to our goal of protecting every American's right to breathe safe air."

"I commend the EPA for finalizing regulations in a way that will reduce EtO emissions by more than 90% at facilities across the country," said Schneider. "I appreciate that the EPA followed the science to keep Americans safe while also ensuring safe, reliable supply chains forhospitals, physicians and patients. I have long fought for sensible regulations to address EtO air emissions and assist impacted communities. Today's regulations will rightly require continuous air monitoring to assure communities that the air they breathe is safe, as well as provide an on-ramp for facilities to comply so that we do not have to choose between safe air and a stable supply of medical products. I will continue to be an outspoken advocate for air monitoring in communities where sterilization facilities are present, and I will always fight to prevent harmful toxins from entering our air."

EPA's science-based review and extensive public engagement process resulted in a comprehensive regulation of the almost 90 commercial sterilizers' EtO emissions, including:

• Establishing standards for currently unregulated emissions, such as building leaks ("room air emissions") and chamber exhaust vents, to reduce cancer risk and account for technological developments in pollution control;
• Strengthening standards that are on the books for sources such as sterilization chamber vents and aeration room vents;
• Requiring continuous emissions monitoring and quarterly reporting formost commercial sterilizers that will provide communities, states, Tribes, and local governments, and EPA with data to ensure EtO emissions are not entering the outdoor air; and
• Ensuring that sterilizers are subject to emission standards during periods of startup, shutdown, and malfunction so there is continuous clean air protection.

Last November, Durbin, Duckworth, and Schneider released a statement regarding a report released by the Centers for Disease Control and Prevention (CDC) and the Agency for Toxic Substances and Disease Registry (ATSDR) evaluating the public health impacts of the EtO, a cancer-causing agent, emitted from the now-closed Sterigenics medical sterilization facility in Willowbrook, Illinois. In the report, ATSDR concluded that, prior to February 15, 2019, long-term breathing of air within one mile of the Sterigenics facility is a concern for increased lifetime risk of cancer associated with EtO exposure, due to the gas' concentration in the air during the sterilization operations at the facility. The report also found that the air within a mile of where the facility no longer poses significant risk to residents as the Sterigenics facility is no longer operational.

Durbin, Duckworth, and Schneider have been strong advocates foraddressing the unacceptable level of EtO emissions. In July 2023, the lawmakers led a letter signed by 40 Members of Congress to EPA supportingthe proposed EtO sterilizer rule. Durbin, Duckworth, and Schneider have also previously introduced legislation that would require EPA to update EtO emissions standards to reflect the stricter criteria outlined in EPA's 2016 IRIS study. Under the bill, any updates to the emissions standards would have to incorporate the maximum achievable control technology requirements to exhaust vents and apply to both area and major sources, which covers plants like Sterigenics. It would also require EPA to undergo a residual risk assessment following implementation of the new rule, which is a stringent and public-health focused review of the rule's impacts.

The lawmakers have also met with the CEO of Sotera Health, the parent company of Sterigenics; convened meetings with then-EPA Administrator Andrew Wheeler on the issue; and sat down with Willowbrook residents.

EtO serves a variety of industrial purposes, including as a sterilizer for 50 percent of sterile medical devices. In 2016, EPA identified EtO as a human carcinogen and included the chemical in the National Air Toxics Assessment. Subsequently, EPA identified communities that faced potentially dangerous levels of EtO emissions from 86 EtO commercial sterilizers in the U.S., which are now required to comply with EPA's March 2024 rule.

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